PMID- 32001385 OWN - NLM STAT- MEDLINE DCOM- 20210629 LR - 20210629 IS - 1878-1632 (Electronic) IS - 1529-9430 (Linking) VI - 20 IP - 6 DP - 2020 Jun TI - Measuring clinically relevant improvement after lumbar spine surgery: is it time for something new? PG - 847-856 LID - S1529-9430(20)30022-X [pii] LID - 10.1016/j.spinee.2020.01.010 [doi] AB - BACKGROUND CONTEXT: Minimum clinically important difference (MCID) for patient-reported outcome measures is commonly used to assess clinical improvement. However, recent literature suggests that an absolute point-change may not be an effective or reliable marker of response to treatment for patients with low or high baseline patient-reported outcome scores. The multitude of established MCIDs also makes it difficult to compare outcomes across studies and different spine surgery procedures. PURPOSE: To determine whether a 30% reduction from baseline in disability and pain is a valid method for determining clinical improvement after lumbar spine surgery. STUDY DESIGN: Retrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database. PATIENT SAMPLE: There were 23,280 participants undergoing elective lumbar spine surgery for degenerative disease who completed a baseline and follow-up assessment at 12 months. OUTCOME MEASURES: Patient-reported disability (Oswestry Disability Index [ODI]), back and leg pain (11-point Numeric Rating Scale [NRS]), and satisfaction (NASS scale). METHODS: Patients completed baseline and a 12-month postoperative assessment to evaluate the outcomes of disability, pain, and satisfaction. The change in ODI and NRS pain scores was categorized as met (>/=30%) or not met (<30%) percent reduction MCID. The 30% reduction from baseline was compared with a wide range of well-established absolute point-change MCID values. The relationship between 30% reduction and absolute change values and satisfaction were primarily compared using receiver operating characteristic (ROC) curves, area under the curve (AUROC), and logistic regression analyses. Analyses were conducted for overall scores and for disability and pain severity categories and by surgical procedure. RESULTS: Thirty percent reduction in ODI and back and leg pain predicted satisfaction with more accuracy than absolute point-change values for the total population and across all procedure categories (p<.001), except for when compared with the highest absolute point-change threshold for leg pain (3.5-point reduction). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 21.8%) and bed-bound disability (ODI 81%-100%: 13.9%) categories. For pain, there was a 3.4%-12.4% and 1.3%-9.8% AUROC difference for no/mild back and leg pain (NRS 0-4), respectively, in favor of a 30% reduction threshold. CONCLUSIONS: A 30% reduction MCID either outperformed or was similar to absolute point-change MCID values. Results indicate that a 30% reduction (baseline to 12 months after surgery) in disability and pain is a valid method for determining clinically relevant improvement in a broad spine surgery population. Furthermore, a 30% reduction was most accurate for patients in the lowest and highest disability and lowest pain severity categories. A 30% reduction MCID allows for a standard cut-off for disability and pain that can be used to compare outcomes across various spine surgery procedures. CI - Copyright (c) 2020 Elsevier Inc. All rights reserved. FAU - Asher, Anthony M AU - Asher AM AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA. FAU - Oleisky, Emily R AU - Oleisky ER AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA. FAU - Pennings, Jacquelyn S AU - Pennings JS AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA. FAU - Khan, Inamullah AU - Khan I AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA. FAU - Sivaganesan, Ahilan AU - Sivaganesan A AD - Department of Neurological Surgery, Vanderbilt University Medical Center, 1161 21st Ave South, T4224 Medical Center North, Nashville, TN 37232, USA. FAU - Devin, Cinton J AU - Devin CJ AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA; Steamboat Orthopedic and Spine Institute, 940 Central Park Dr #280, Steamboat Springs, CO 80487, USA. FAU - Bydon, Mohamad AU - Bydon M AD - Department of Neurologic Surgery, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA. FAU - Asher, Anthony L AU - Asher AL AD - Carolina Neurosurgery and Spine Associates, 225 Baldwin Ave, Charlotte, NC 28204, USA. FAU - Archer, Kristin R AU - Archer KR AD - Department of Orthopedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Ave South, Medical Center East, South Tower, Suite 4200, Nashville, TN 37232, USA; Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, 2201 Children's Way, Suite 1318, Nashville, TN 37212, USA; Osher Center for Integrative Medicine, Vanderbilt University Medical Center, 3401 West End Avenue, Suite 380, Nashville, TN 37203, USA. Electronic address: kristin.archer@vumc.org. LA - eng PT - Journal Article DEP - 20200128 PL - United States TA - Spine J JT - The spine journal : official journal of the North American Spine Society JID - 101130732 SB - IM MH - Disability Evaluation MH - *Elective Surgical Procedures MH - Humans MH - Lumbar Vertebrae/surgery MH - Prospective Studies MH - Retrospective Studies MH - *Spine MH - Treatment Outcome OTO - NOTNLM OT - Disability OT - Elective spine surgery OT - Lumbar spine OT - Minimum clinically important difference OT - Pain OT - Patient reported outcome measures OT - Satisfaction EDAT- 2020/02/01 06:00 MHDA- 2021/06/30 06:00 CRDT- 2020/02/01 06:00 PHST- 2019/07/29 00:00 [received] PHST- 2020/01/22 00:00 [revised] PHST- 2020/01/23 00:00 [accepted] PHST- 2020/02/01 06:00 [pubmed] PHST- 2021/06/30 06:00 [medline] PHST- 2020/02/01 06:00 [entrez] AID - S1529-9430(20)30022-X [pii] AID - 10.1016/j.spinee.2020.01.010 [doi] PST - ppublish SO - Spine J. 2020 Jun;20(6):847-856. doi: 10.1016/j.spinee.2020.01.010. Epub 2020 Jan 28.